Practice

Medical Device Law

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. After your product debuts, the challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations.

Hogan Lovells Publications

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise? Medical Device Alert

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available ...

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Webinar

Modifications to 510(k) - Cleared devices: Assessing the impact of FDA's 2017 final guidance documents

On December 6, Danielle Humphrey and Kristin Zielinski Duggan led a complimentary webinar, which covered:

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Hogan Lovells Publications

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling Pharmaceutical and Biotechnology Alert

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on ...

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